MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 4/0(1,5)4X70CM HR22(MDDP; SUTURES

Model Number C0024707

Device Problems Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 open pouch.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed in the market (b)(4) units of this code batch.There are no units in stock.Received one open and unused sample.One of the four sutures inside the pouch has the needle detached from the thread.All sutures are still wound on the pack.Tested the needle attachment of the other three sutures of the pack and the results fulfill the oem requirements.Taking into account that no other customer complaints have been received concerning this issue for this code batch, this is considered an isolated unit affecting only this article code batch.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Final conclusion: in spite of receiving a defective unit, the results of the other sutures of the pack fulfill the oem specifications.Note of this incident is taken in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

Country of complaint: (b)(6).It was reported that the needle was loose in the package and adhered to the foil.It is possible that the needle fell into the patient.All med watch submissions related to this report are: 3003639970-2017-00128, 3003639970-2017-00129.

• Brand Name: MONOPLUS VIOLET 4/0(1,5)4X70CM HR22(MDDP
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6415185
• MDR Text Key: 70326063
• Report Number: 3003639970-2017-00128
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: C0024707
• Device Catalogue Number: C0024707
• Device Lot Number: 116304V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Distributor Facility Aware Date: 03/06/2017
• Device Age: 7 MO
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other